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Three drug companies comment on an FDA draft guidance on immune-mediated adverse reactions in cancer drug trials.[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Conflict-of-Interest Information for Partic...[ Price : $8.95]
A new Government Accountability Office report offers recommendations to shield FDA and other HHS agencies from political interfere...[ Price : $8.95]
FDA posts a draft guidance entitled Pulmonary Tuberculosis (TB): Developing Drugs for Treatment.[ Price : $8.95]
FDA publishes a draft guidance defining the types of behaviors that FDA considers to be delaying, denying, or limiting an inspecti...[ Price : $8.95]
Three Ropes & Gray attorneys describe the potential for a Circuit Courts of Appeals split over FDA authority in regulating stem ce...[ Price : $8.95]
Federal Register notice: FDA announces the two-year renewal of its Endocrinologic and Metabolic Drugs Advisory Committee.[ Price : $8.95]
Federal Register notice: FDA announces that a priority review voucher was redeemed in the 5/23 approval of United Therapeutics sup...